The P3NET alliance offers comprehensive services to support antimicrobial drug development.
We are specialized in translational and clinical pharmacology of antimicrobials, offering expertise, infrastructure and capabilities on clinical studies, bioanalytical services, preclinical in vitro models, and computational PK/PD modeling for antimicrobials.
Unique of P3NET is that our services are integrated and aligned within a single alliance of experts in antimicrobial drug development. P3NET offers a one-stop-shop to support antimicrobial drug development, at academic rates.
Overview of our services
Early Phase Clinical studies
P3NET can support the design, execution and analysis for a range of early phase clinical studies in healthy volunteers and patients, through the clinical trial unit at the Medical University of Vienna.
- Drug-drug interactions studies
- Special patient population PK studies (renal & hepatic impairment, diabetic foot, critically ill)
- Tissue PK studies (microdialysis, BAL, PET)
- Bioequivalence studies
- Phase 2 dose finding studies
Pharmaceutical analysis & Translational PK/PD
P3NET can support development of bioanalytical methods for antimicrobial PK as well as routine analysis of clinical trial samples, at the bioanalytical PK laboratories of Radboud University Medical Center. In addition, wide experience in in vitro PK/PD models exists at P3NET partners to guide translational development of antimicrobials.
- Bioanalytical method development
- Sample bioanalysis with rapid turnaround times
- In vitro PK/PD studies (time kill, HFIM)
Pharmacometrics & PKPD modeling
P3NET has extensive experience in the use of pharmacometrics & PKPD approaches to support preclinical and clinical development of antimicrobialy, under coordination of Leiden University.
- Population PK modeling for dose selection and dose individualization
- PBPK modeling to predict tissue exposure
- Translational PK/PD modeling to support phase 2 dose selection
- Model-informed dose selection for first-in-man studies
- Optimization of clinical trial designs n
Strategic consulting
P3NET can provide strategic advice to support the translational and clinical development of novel antimicrobial compounds, providing input on translational and clinical development strategies.
- Target product profile selection
- Preclinical and clinical development strategy
- PK/PD methodologies